Specimen sample collection device and test system

ABSTRACT

A specimen sample collection device and test system includes a handle with a sufficiency indicator and locking teeth, an absorbent pad partially contained within the handle; a pad compression tube with outlet ports and locking holes insertable over the pad and handle; one or more collection tubes attachable to the pad compression tube outlet ports. The apparatus may include a light pipe sufficiency indicator with a spring compressor to force the absorbent pad into contact with the light pipe. The apparatus may include a collector dam. The apparatus may include a secondary seal. The apparatus may include a cylindrically shaped absorbent pad and a wrap-around light pipe sufficiency indicator with vent grooves. The apparatus may include a pad seat with buffer material disposed within the pad compression tube. The apparatus may include an absorbent pad split and divided into two lengths connected at a base. The apparatus may include a bar code identification. The apparatus may include a lock and key securing mechanism. The apparatus may include a handle containing one or more analyte test strips The apparatus may include a first absorbent pad in fluid communication with a sample adequacy indicator, which is in parallel with a second absorbent pad in fluid communication with a lateral flow analyte test strip. The apparatus ma include a first absorbent pad in fluid communication with a sample adequacy indicator, which is in parallel with a second absorbent pad in fluid communication with a lateral flow analyte test strip, with an impermeable membrane separating the first and second absorbent pads.

CROSS-REFERENCE TO RELATED APPLICATION

This application is a nonprovisional application claiming priority toprovisional patent application Ser. No. 61/123,378, filed Apr. 7, 2008,and which is herein incorporated by reference.

FIELD OF THE INVENTION

The present invention relates to devices and methods for the collectionof fluids, and more particularly to devices and methods for thecollection of fluids and methods for testing samples so obtained forfluids including bodily fluids such as saliva.

BACKGROUND

Traditional methods of testing for diseases, drugs and other antigens inhumans have up until the last few years been predominantly done usingblood samples. These samples collected in laboratories at the request ofphysicians require that blood drawn by a trained phlebotomist is sent toa laboratory and the serum component comprising a predominance ofimmunoglobulins, containing antibodies to the disease or disease statein question, is tested using a variety of available test kits to assistin the diagnosis of various diseases including infectious diseases,cardiovascular diseases, cancers and many others. Such samples can alsobe tested for the presence of non-disease analytes such as metals,minerals, DNA, bacteria and organic molecules among others.

Under current standardized laboratory practices, it is necessary toconfirm any initially positive result obtained from diagnostic oranalytical testing with a more sensitive (accurate) method. This, infact is true for most, if not all diagnostic tests used today,including, as an example, HIV tests, which are confirmed by moredefinitive methods such as Western blot techniques or immunofluorescence(IFA) assays. In the case of drug tests, for instance, performed incriminal justice settings (at the police car, in correctionalfacilities, in drug courts, etc.) or at the workplace, by way of twoexamples, confirmation is carried out using gas chromatography-massspectrometry (GC-MS), gas chromatography-massspectrometry-mass-spectrometry (GC-MS-MS) or liquid chromatography-massspectrometry-mass spectrometry (LC-MS-MS) on a second sample taken fromthe subject. Other diagnostic and screening methods require similarlyaccurate methods for confirmatory purposes.

The United States Substance Abuse Mental Health Services Administration(SAMHSA), the designated body responsible for regulating Federal drugtesting in the United States, has recently prepared guidelines for theintroduction of new tests and sample collection procedures for drugtests using so-called, “alternate” specimens. These sample types includesaliva (or oral fluids), hair and sweat. These guidelines define theneed for (1) a confirmatory specimen to be collected at the time of theinitial sampling, (2) defined specimen volumes to be collected and (3)expected drug cut-off values, among other requirements.

The need for duplicate or a multiplicity of mutually distinct samplestaken from the same source at the same time is part of a general trendbeing observed in many areas of the diagnostic and analytical testingbusinesses. The main reason for this increasingly important trend is thelegal implication of being able to definitively rule out any potentialcontamination of the test sample during the testing process. The obviousconsequences of an incorrect diagnosis of HIV for a patient or erroneousDNA results in the case of a criminal case are just two examples ofwhere 100% certainty of sample integrity are paramount and arecontributing reasons for the development of this particular invention.This potential legal implication has had an impact on general testingprotocols and as a result healthcare and other professionals are nowmore cognizant than ever of the need to collect a “pure” sample orsamples then ensure that those samples are analyzed to produce accurateresults. During the testing process absolute “chain-of-custody” rulesare enforced to ensure that no adulteration or contamination of thespecimen occurs. This is not always possible in current testingprotocols as there are opportunities for sample contamination or sampletampering. This is true for any test whether done on blood, serum,saliva, nasal secretions, vaginal discharge or any other sample whereinformation obtained relates to a diagnosis of disease or disease state.Such information is taken in conjunction with any additional informationavailable to the person making a decision relating to interpretation ofthe results obtained.

Despite the fact that saliva has been used as a diagnostic fluid sinceAncient Chinese times, when the “Rice Test” (which relied on theinhibition of saliva as a determinate of guilt) was used, it is onlyover the last few years that salivary testing has taken on much greatersignificance. There are several important factors, which havecontributed to this change: (1) The increase in popularity of non- orless-invasive testing methods; (2) the availability of more sensitiveantibodies and antigens for detection of immunoglobulins in saliva; (3)new technologies in the area of point-of-care testing; (4) a need formore rapid results; (5) acquisition of serum/blood involves patientdiscomfort and can cause difficulty particularly where young children orintravenous drug users are concerned; (6) use of venous blood to collectserum requires capital equipment and involves an initial processingstep, which adds significant time to result turnaround and hasadditional cost implications and also; (7) a general movement away fromcentralized laboratory testing towards “near-patient” testing, alsocalled “point-of-care” testing.

The National Institutes of Health (NIH) recognized the value of salivarytesting as early as 1993 and recent symposia orchestrated by thisorganization, for instance a meeting held in 1999, organized by NIH'sNational Institute of Dental and Craniofacial Research (NIDCR) divisionhas helped increase the profile of testing using oral fluids. NIH,through various divisions, has since been encouraging companies withexpertise in this area to apply for funding for new projects aimed atintroducing novel tests using non-invasive samples for laboratory andpoint-of-care applications.

The insurance testing industry uses saliva as a sample matrix forapplicants wishing to purchase specific life insurance policies as asafeguard measure prior to writing policies. In these situationsapplicants are tested for HIV, cotinine (nicotine) and cocaine using atesting device called “OraSure” from OraSure Technologies, whichcollects oral fluids for subsequent testing under laboratory conditions.Each of the major insurance testing laboratories in the United Statesperforms a significant number of oral fluid tests on an annual basis.

In April 2004 OraSure Technologies was successful in gaining FDAapproval for its OraQuick® HIV 1/2 rapid test for oral fluid diagnosisof the HIV viruses type 1 and type 2. Previously the test had beenapproved by the agency for whole blood, serum and plasma only.

In a separate area drugs of abuse are routinely detected from oralfluids collected in the workplace, in criminal justice settings and inhospitals using OraSure Technologies' “Intercept™” device and associatedrange of ELISA microplate assays. In this case a panel of 5 “abused”drugs or more are measured under laboratory conditions.

Rapid testing devices using saliva have recently appeared which may beused at the “point-of-care”. These devices can collect and performimmediate testing for several drugs of abuse but these suffer from poorperformance for certain tests at the present time, particularlyTetrahydrocannabinol (THC) or its major metabolite11-nor-Δ9-Tetrahydrocannabinol. Examples of this type of device are theOraTect™ test from Branan Medical Corporation, the OraLine assay fromSun Biomedical and the Cozart BioScience RapiScan device, among others.

Up until now urine based rapid drug testing has been performedpreferentially due to availability, cost, and to a certain extent, alack of salivary tools incorporating some of the features described inthis invention. While rapid urine kits are widespread they suffer fromissues related to “chain-of-custody”, the need for facilities to collecturine specimens discreetly under appropriate supervision and are easilyadulterated by knowledgeable users, who can “cheat” such tests.

Electronic reading, hand-held devices, such as the Cozart BioSciencesRapiScan instrument are also now available outside of the United States,that allow immediate drug testing to be done from oral fluids at theroadside and other field settings. This technology requires samplecollection from the donor then immediate testing on site. This conceptmay well be duplicated in the future, as technologies to “miniaturize”testing platforms, improves.

The FDA has approved a laboratory HIV test, OraSure HIV-1 for testingfor the HIV-1 virus from oral fluid as well as a Western blotconfirmatory test, which also uses oral fluids. Both have been used in aPublic Health setting in the United States for over five (5) years.

In addition the FDA has also approved saliva tests for pre-term labor(SalEst™, salivary estriol, from Biex, Inc), a salivary alcohol test(QED®, OraSure Technologies), a cortisol assay (Salimetrics, Inc.) aswell as a panel of saliva-based drug assays (Intercept, OraSureTechnologies) through the 510(k) clearance system. A number of otheroral fluid drug testing products are undergoing regulatory approval, soin the next 12-24 months we might expect to see several other productsavailable in the U.S. Furthermore, “investigational use” tests areavailable for immunoglobulins, for example sIgA (for use inpsychological disorders, stress and athletic performance), therapeuticdrugs (for instance lithium, theophylline, AZT), tumor markers (e.g.Her-2/neu), bacterial antibodies such as helicobacter pylori and evengenomic detection of mitochondrial DNA (for criminal justiceapplications) using oral fluids as the preferred specimen matrix.

Emerging methodologies based on microfluidic technology requiring onlysmall quantities of specimen samples are approaching the market. Thesedevices work on virtually any specimen matrix including, but not limitedto, saliva, urine, whole blood, serum, and other fluids. Such techniqueshave already found use in the arena of biodefense monitoring, highthroughput screening methods, high performance liquid chromatography(HPLC) and other analytical techniques. These devices, which are beingdeveloped in one particular area for use by special intelligence forces,who are required to test for chemical and biological agents in soil,water and other samples before troops arrive at a battle site or duringpeacekeeping to monitor biological or environmental samples, may be seenas another area where this invention will find application.

These are a few of the many instances where saliva is viewed as a viablesample matrix for testing purposes. A number of devices in use todayhave provided means for the collection of bodily fluids including salivaand urine among others. One FDA-cleared fluid collection device usedpredominantly for saliva collection and testing has been shown to bepotentially unsafe in pediatric patients. The Saliva-Sampler™ devicefrom SDS, Inc. utilizes perforations present on filter paper tofacilitate removal of the filter paper for subsequent saliva separationand testing. The device is placed under the tongue to accumulatesublingual whole saliva, collected by leaving the sampling device,consisting of a filter paper material attached to a plastic stem, inposition until a sample indicator built into the device changes colorconfirming sample sufficiency. The process requires that the subject notchew, bite or unnecessarily move the device during the collectionprocedure. In pediatric patients, particularly, this can be a problem aschildren have a tendency to chew on materials placed in the oral cavity.In infants, separation of the filter paper prematurely can result inchoking.

In another previously described example, an alternate FDA-approved oralfluid collection system from OraSure Technologies, Inc., known asOraSure®, incorporates salts impregnated on to the collection medium inthe form of a “hypertonic” solution. According to the manufacturers, thepurpose of the salts is to facilitate ready absorption of oral fluids(oral mucosal transudate) from the gingival crevices and thereby reducesampling time. In practice when the OraSure® device is placed in theoral cavity, the taste of the salts on the device medium may bedistasteful to potential users.

These and other currently available devices fail to address a growingneed for efficient collection of bodily fluids including saliva forapplications including analytical or diagnostic testing underlaboratory, field or point-of-care testing conditions, for instance,whereby a pure sample of fluid, for example saliva, is collected from asubject and split into multiple chambers, thereby providing a means forinitial specimen testing analysis or storage, for confirmation orsupplementary testing and simultaneously providing a mechanism forconfirming sample sufficiency prior to any subsequent testing oranalysis of the constituents of the bodily fluid so collected.

Lateral flow immunochromatography (ICT) tests have been around for overa decade and are a direct descendent of thin-layer chromatography (TLC)techniques pioneered during the 1970s. The technology offers somebenefits including cost efficiencies, user-friendliness and theavailability of immediate test results. Over the last decade inparticular, the availability of high quality raw material components,the growing movement towards near patient or point-of-care (“POC”)testing, coupled with a need for rapid results, has led to an“explosion” in the development and commercialization of bothflow-through and lateral flow devices based on immunochromatographictest principles. These devices form part of a rapidly growing industryfor diagnostic tests performed outside of the laboratory.

A variety of ICT tests are now available including as examples OraSureTechnologies' rapid oral fluid test, OraQuick HIV 1/2, QuidelCorporation's Quick-Vue Streptococcus A and Helicobacter pylori rapidtests, Meridian BioSciences' ImmunoCard assays for RespiratorySyncticial Virus (RSV) and Clostridium Difficile (C. Difficile) andRoche Diagnostics' TestCup drugs of abuse tests among a multitude ofothers.

Technologies other than ICT are equally adaptable to rapid testing.These include latex agglutination, dot-blot tests, microarrays andothers.

Of the above rapid test examples and those currently in existence, onlyOraSure Technologies has been successful in commercializing a rapid,oral fluid test, OraQuick HIV 1/2, despite the fact that oral fluid,point-of-care tests represent an attractive alternative to currenttesting methodologies. This may be due, in part, to current datarequirements for approval of rapid tests in the U.S. This is expected tochange as a result of OraSure's success with OraQuick® HIV 1/2 and theemergence of saliva-based drug testing assays.

In order to meet the needs of a growing Public Health demand in the U.S.it is important for would-be manufacturers to integrate test striptechnologies similar to those mentioned above with a simple-to-use,integrated platform system that can deliver rapid test results, safelyand cost-effectively, for a range of diseases or analytes in anon-invasive manner. This is especially important in view of Centers forDisease Control (CDC) estimates that suggest that, of 2.1 million peopletested at Publicly-funded Government testing sites using traditional(laboratory) testing methods in the US for the HIV virus, approximately33% do not return to receive their results and may unwittingly go on toinfect others if they are in fact HIV-positive. As the key to alldisease prevention is early detection, accurate and early detectionusing rapid tests can have a major impact on reducing disease incidence.

In needle-averse populations, for instance, small children, pregnantwomen and hemophiliacs, the opportunity to provide oral fluid or salivacollection and immediate testing as an alternative to blood-basedsystems would be welcomed. Similarly general practitioners and healthprofessionals would see an opportunity to provide testing opportunitiesin non-traditional testing sites, such as in the privacy of thepatient's home, in nursing homes, remote clinic settings and even overthe counter in a pharmacy environment.

Cozart BioSciences (UK, www.Cozart.co.uk)) has described the use of ahand-held device known as RapiScan, which tests for several illicit drugentities from oral fluids. This reading system is not fully integratedand requires a separate collection step prior to testing the specimen.OraSure Technologies (www.OraSure.com) has also described in a recent USPatent Application (Application Number unknown at this time), the use ofa sample collector and test device. In this example also, samplecollection is distinct from the specimen testing process.

SAMHSA has proposed in its 2004 guidelines for alternate specimentesting that minimum oral fluid collection volumes are to be 2 mL ofclean specimen.

None of the available prior art provides for expressing an oral fluidsample from a subject directly onto a diagnostic test strip, providing amechanism for determining sample volume adequacy and visually readingqualitative and/or quantitative results from the test strip through asmall window in an integrated one-step manner.

The following represents a list of known related art U.S. Pat. No.5,283,038 issued Feb. 1, 1994, U.S. Pat. No. 5,260,031 issued Nov. 9,1993, U.S. Pat. No. 5,268,148 issued Dec. 7, 1993, U.S. Pat. No.5,393,496 issued Feb. 23, 1995, U.S. Pat. No. 5,380,492 issued Jan. 10,1995, U.S. Pat. No. 5,376,337 issued Dec. 27, 1994, U.S. Pat. No.6,267,722, U.S. Pat. No. 6,027,943, U.S. Pat. No. 6,187,598, U.S. Pat.No. 5,965,453, U.S. Pat. No. 5,393,496, U.S. Pat. No. 4,943,522, U.S.Pat. No. 4,895,808, U.S. Pat. No. 6,372,516, U.S. Pat. No. 6,046,058,U.S. Pat. No. 5,962,336, U.S. Pat. No. 5,238,652, U.S. patentapplication Ser. No. 10/061,036 by Lloyd Simonson, U.S. patentapplication Ser. No. 10/060,605 by Lloyd Simonson, U.S. Pat. No.6,627,152, U.S. Pat. No. 6,727,879, U.S. Pat. No. 5,922,614 to EdwardCesarczyk, U.S. Pat. No. 6,489,172. None of the above inventions andpatents, taken either singularly or in combination, is seen to describethe instant invention as claimed.

SUMMARY AND ADVANTAGES

A specimen sample collection device and test system includes a handlehaving a sufficiency indicator and unidirectional locking teeth onopposing sides of the handle, an absorbent pad partially containedwithin said handle, a pad compression tube insertable over saidabsorbent pad within said handle and around an end of said handle,wherein the pad compression tube includes locking holes on opposingsides distributed along its length to engage the unidirectional lockingteeth, and a collection tube having one or more sample chambers,attachable to said pad compression tube, and wherein said compressiontube defines one or more chambers, and wherein when said collection tubeis attached to said pad compression tube, the chambers are in fluidcommunication with said pad compression tube. A specimen samplecollection device includes a sufficiency indicator made up of a lightpipe indicator window. A specimen sample collection device includes asufficiency indicator made up of a light pipe indicator window with aspring compressor. A specimen sample collection device includes anabsorbent pad split and divided into two lengths connected at a base. Aspecimen sample collection device includes a bar code identification. Aspecimen sample collection device and test system includes a lock andkey securing mechanism. A specimen sample collection device includes ahandle containing one or more analyte test strips A specimen samplecollection device and test system includes an electro-optical a reader.A specimen sample collection device and test system includes a firstabsorbent pad in fluid communication with a sample adequacy indicator,which is in parallel with a second absorbent pad in fluid communicationwith a lateral flow analyte test strip. A specimen sample collectiondevice and test system includes a first absorbent pad in fluidcommunication with a sample adequacy indicator, which is in parallelwith a second absorbent pad in fluid communication with a lateral flowanalyte test strip, with an impermeable membrane separating the firstand second absorbent pads.

The specimen sample collection device and test system of the presentinvention presents numerous advantages, including: (1) ability tocollect appropriate volumes of specimen sample and confirmation sampleusing a split (fork-shaped) collection medium; (2) ergonomically correctdesign; (3) simple to use; (4) ability to adapt to new testingrequirements; (5) sample containment with minimized chance ofcontamination; (6) utilizes an absorbent pad collection medium ratherthan a filter paper collection medium; (7) provides a unique sampleindicator design that does not utilize a compressible sponge orpolymeric bead; (8) provides a unique sample indicator design that doesnot involve disposing an indicator on filter paper; (9) provides aunique sample indicator design that does not require an adequacyindicator separate from the collection medium; (10) utilizes acollection medium that does not require a rectangular or paddle shape;(11) allows for samples to be removed from individual compartments orchambers and channeled directly or pipetted if necessary, directly intoan alternate receptacle for further analysis or testing; (12) allows forremoval of the specimen directly using high-throughput automatedequipment, which can speed up sampling and analysis tremendously. (13)allows for collection of mutually distinct samples for initial testingor analysis and follow up or supplementary testing either immediately orat a later date; (14) allows for use of “tailored” buffer solutionsdesigned to protect the integrity of various different analytes orsamples collected; (15) utilizes multiple absorbent materials tomaximize the retention and release properties of the invention; (16)allows for testing samples collected immediately using available lateralflow immunochromatographic test strips to deliver test results at thepoint of care; (17) allows for collection of specimen without the needfor an additional filtration or centrifugation step; (18) requires noexpensive capital equipment to collect and process the sample; (19)allows for individual sample identification; (20) allows for a varietyof sample collection tubes to be attached to the end of the inventiondepending upon sample volume requirements and whether single or dualsampling is required; (21) requires minimum manipulation of fluidspecimen; (22) minimizes the chance for contamination of the samplecollected; (23) minimizes the chance of tampering with the samplecollected; (24) provides the ability to rule out contamination; (25)reduces the opportunity for misdiagnosis; (26) provides the ability towork within “chain-of-custody” protocols; (27) provides the ability toobtain a rapid test result and a confirmatory result; (28) utilizes anintact pad material and does not require that the absorbent pad materialbe separated from the main sampling device, so there is a significantlyreduced chance of the pad separating in the subject's mouth when used innormal practice; (29) does not require the use of any salts or hypotonicsolutions impregnated in the collection medium to improve collectiontime; (30) provides the ability to deliver fluids to two test strips ortwo separate receiving ports at the same time; (31) parallel absorbentpads allow a more compact design; and, (32) parallel absorbent padsallow using pads with different absorbent characteristics to optimizeresults.

Additional advantages of the invention will be set forth in part in thedescription which follows, and in part will be obvious from thedescription, or may be learned by practice of the invention. Theadvantages of the invention may be realized and attained by means of theinstrumentalities and combinations particularly pointed out in theappended claims. Further benefits and advantages of the embodiments ofthe invention will become apparent from consideration of the followingdetailed description given with reference to the accompanying drawings,which specify and show preferred embodiments of the present invention.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings, which are incorporated into and constitute apart of this specification, illustrate one or more embodiments of thepresent invention and, together with the detailed description, serve toexplain the principles and implementations of the invention.

FIG. 1 shows an embodiment of a specimen sample collection device andtest system.

FIG. 1 a shows a schematic view of a specimen sample collection deviceand test system with a pad compression tube attached to a handleincluding locking teeth.

FIG. 2 shows a light pipe indicator window over a dry absorbent pad.

FIG. 3 shows a light pipe indicator window over a saturated absorbentpad

FIG. 3 a shows a light pipe indicator window over a saturated absorbentpad including a spring compressor.

FIG. 4 shows another view of a specimen sample collection device.

FIGS. 5 a, 5 b, and 5 c show different views of a pad compression tube.

FIG. 5 c shows the view of FIG. 5 a from the side.

FIGS. 6 a, 6 b, and 6 c show different views of a chambered collectiontube.

FIG. 6 b shows the view of FIG. 6 a from the side.

FIG. 7 shows a schematic view of a specimen sample collection device andtest system with a pad compression tube attached to a handle.

FIG. 8 shows another embodiment of a specimen sample collection deviceand test system.

FIG. 9 shows another embodiment of a specimen sample collection deviceand test system.

FIG. 10. shows the interior layout of a specimen sample collectiondevice.

FIG. 11 shows an embodiment of an absorbent pad.

FIG. 12 shows another embodiment of an absorbent pad.

FIG. 13 shows an embodiment of a sample adequacy indicator using aspring set into a sponge.

FIG. 14 shows a cross-sectional view of an embodiment of a specimensample collection device with parallel absorbent pads.

FIG. 15 shows a perspective view of an embodiment of a specimen samplecollection device with alignment posts for a collector dam.

FIG. 16 shows a perspective view of an embodiment of a specimen samplecollection device with a collector dam installed on the collectorhandle.

FIG. 17 shows a perspective view of an embodiment of a specimen samplecollection device with a collector dam installed and a split absorbentpad.

FIG. 18 shows an exploded view of an embodiment of a specimen samplecollection device with a collector dam, a unitary absorbent pad, and apad seat.

FIG. 19 shows a perspective view of an embodiment of a specimen samplecollection device with a round cylindrical absorbent pad.

FIG. 20 shows multiple cross-sectional views of an embodiment of aspecimen sample collection device with a round cylindrical absorbent padand a wrap-around light pipe with ventilation grooves.

FIG. 21 shows a perspective view of an embodiment of a specimen samplecollection device with a round cylindrical absorbent pad and awrap-around light pipe.

DETAILED DESCRIPTION

Before beginning a detailed description of the subject invention,mention of the following is in order. When appropriate, like referencematerials and characters are used to designate identical, corresponding,or similar components in differing figure drawings. The figure drawingsassociated with this disclosure typically are not drawn with dimensionalaccuracy to scale, i.e., such drawings have been drafted with a focus onclarity of viewing and understanding rather than dimensional accuracy.

In the interest of clarity, not all of the routine features of theimplementations described herein are shown and described. It will, ofcourse, be appreciated that in the development of any such actualimplementation, numerous implementation-specific decisions must be madein order to achieve the developer's specific goals, such as compliancewith application- and business-related constraints, and that thesespecific goals will vary from one implementation to another and from onedeveloper to another. Moreover, it will be appreciated that such adevelopment effort might be complex and time-consuming, but wouldnevertheless be a routine undertaking of engineering for those ofordinary skill in the art having the benefit of this disclosure.

As shown in FIGS. 1-4, a specimen sample collection device 10 includes ahandle 14 with a sufficiency indicator, such as a light pipe indicatorwindow 18, and an absorbent pad, which can be a rounded tongue absorbentpad 15. As shown in FIG. 1, a specimen sample collection device and testsystem 12 includes a specimen sample collection device 10, a padcompression tube, which can be a dual outlet single channel compressiontube 20, and a collection tube, which can be a chambered collection tube26.

Absorbent pad 15 fits partially within the handle. As shown in FIGS. 1,4, 7, and 10 at 15, absorbent pad can be rounded to provide theadvantage of comfort to the sample subject. As show in FIGS. 8 and 9 at115, the absorbent pad can be split, i.e., divided into two parts andconnected at the base of the pad to allow for dual sample collection.The split absorbent pad 115 can be prong- or fork-shaped or have splitsof varying length. Those of skill in the art are aware that theabsorbent pad can be divided into more than two parts. In thisembodiment the split absorbent pad 115 is configured such that one prongof the pad can absorb at least 1.0 ml of specimen, and the other pad canabsorb at least 0.5 mL of specimen, when a highly absorbent pad materiale.g. Ahlstrom 320 or Schleicher & Schuell 300 grades are chosen. When asplit, divided, prong or fork shaped absorbent pad is placed into thetest subject's mouth each split or division of said absorbent padabsorbs saliva at the same time, thus collecting identical salivasamples. One of skill in the art would also realize that the absorbentpad could be two or more separate and distinct absorbent pads. Absorbentpad can also be provided with a bifurcated-end in a smooth “m” shape onthe end of the pad interior of the handle to deliver saliva to the endsof two test strips simultaneously.

The absorbent pad soaks up specimen when placed in a specimenatmosphere, such as for example, soaking up saliva when placed in asubject's mouth, preferably under the tongue. Absorbent pad is notfilter paper. Filter paper is designed specifically to have porousopenings to have control or “filter” the size of material passingthrough it. The purpose of the absorbent pad is to collect and dispersea high volume of liquid sample yet remain relatively rigid through thesample collection procedure. Thus, an advantage is obtained by using anabsorbent pad rather than filter paper. Absorbent pad may be a varietyof different materials that will absorb liquid and release or transmitsaid liquid following an action carried out to facilitate removal ofsaid liquid from the pad.

Pad materials have a variety of properties, which may affect the abilityof a substance to adhere (or bind) to that specific absorbent padmaterial effectively, and also for that material to be suitably releasedfrom the pad when required. One particular property is a material'shydrophobic or hydrophilic characteristics. Hydrophilic materials arereadily “wet” with aqueous solutions and so aqueous based fluids, suchas saliva, urine, whole blood, vaginal fluid, etc. (containingantibodies, minerals, and other analytes of interest) will be readilyabsorbed by hydrophilic pad materials and released effectively. In anembodiment of this invention for example, absorbent pad material is madeup of hydrophilic materials from a list including Ahlstrom materialscatalog numbers 270 and 320, Schleicher & Schuell catalog numbers 300and 900 among others. Experimentation has shown that a largecross-section of substances to be detected or measured in fluids can becarried out using one of these versatile products. Hydrophobic padmaterials will not adequately “wet” in aqueous solutions but will bewetted in low surface tension liquids such as alcohols, hence the needfor the addition of low alcohol concentrations in any buffering systemused.

Those skilled in the art know that numerous materials meeting theserequirements exist, such as various cotton linters, for exampleSchleicher & Schuell (US) papers 300, 900, 903 or 2992, fiber compositematerials such as materials available from Ahlstrom (US) for instanceAhlstrom 270, a multi-purpose cellulose material that has been used forfluid collection and release and Ahlstrom grade 320 material, a materialwith hydrophobic characteristics. Also glass fiber, certain polymericmaterials, spunbound polyester materials (e.g. Hollytex brand fromAhlstrom, (US), extruded fibers, other cellulose papers manufacturedfrom raw material cellulose (e.g. Ahlstrom Paper group (US) and Filtrona(US) Transorb® materials), mixed fiber papers (e.g. Whatman (UK) PadsS9036-2009) as well as two-ply materials for example. The properties ofthese materials vary from absorbent materials with low protein bindingcapability to those with high binding capacity. Materials are availablein various thicknesses and sizes and may be easily customized to suitthe specific intended application for the pad material. Already, adiverse range of product materials is available form several sourcesincluding Schleicher & Schuell, Ahlstrom, Filtrona, Porex, Whatman andothers as described above. These materials are typically manufacturedunder strictly controlled conditions to ensure uniform composition andabsorption/release of fluids from the pad. Several of theafore-mentioned materials have been widely used as diagnostic andanalytical testing components and have been certified as suitable forthese purposes. Those skilled in the art know that absorbent padmaterials may also include hydrophilic or hydrophobic components bound,or integrated into the material, such components being capable ofmodifying the absorption and release characteristics of the absorbentpad as well as the speed of uptake of the sample fluid underconsideration. In the majority of cases antibodies minerals andsubstances will be readily removed from the absorbent pad upon squeezingthe pad in the compression tube according to the operationalinstructions supplied herein. However, in certain instances, materialsthat are difficult to remove e.g. hydrophobic materials includingprogesterone, testosterone, estradiol, other steroid hormones andΔ9-Tetrahydrocannabinol (THC), will be collected in a further embodimentusing a pad with hydrophobic properties. In this embodiment a smallpercentage of low molecular weight alcohol (ethanol, methanol orbutanol, for instance) at a concentration of 0.1%-4.0% is added.

The binding characteristics of various protein and other molecules tothe absorbent pad is another important factor. This particular propertyinfluences the nature of the binding of a given material to absorbentpad materials and is carefully considered when choosing products for agiven application. Materials with high-binding characteristics may insome instances be used to encourage removal of certain analytes from theoral cavity, which may be difficult to obtain using pad materials withlower binding characteristics. In these cases, release agents such asalcohols, Tween 20 and others may be used.

Other properties, which can impact the performance of absorbentmaterials and hence the ability to collect an optimum fluid specimeninclude thermal stability, pore size and pad size. The dimensions andmaterials used in embodiments of this invention including Ahlstrom 270 &320, Schleicher & Schuell 300 & 900 cellulose materials and others havebeen well characterized by the manufacturers and are also available inpublished works.

To one skilled in the art there are also a spread of materials whichoffer a choice of “wicking rate”, meaning the rate at which sample fluidis absorbed by the paper or pad material, so it is important foroptimization purposes to work with individual manufacturers of suchproducts to choose the optimum characteristics necessary to achieve thebest results.

To one skilled in the art it is further apparent that modification ofthe properties of the absorbent pad can be made by the addition ofvarious agents at the time of manufacturing the pad material. Thisinvention has been conceived as a means of providing a method forcustomization and optimization of the properties of pad materials for awide range of specific applications for which fluid collection isrequired. Further it is understood by one skilled in the art thatmodification of the dimensions of the pad (for instance thickness,width, height and others) can modify the absorption characteristics ofthe pad material. Materials such as those cited here are availablethrough a number of companies including Whatman (UK), Ahlstrom(Finland), Schleicher and Schuell (US), Porex and Filtrona (US), whichare chosen here by way of examples. While the above list of materials isconsiderable, these may or may not be suitable for the collection ofcertain types of specimens in fluids, for example steroid hormones, THCand certain other drug substances and others, for instance, which have atendency to “stick to” certain pad materials and can be bound tightly.An embodiment of this invention therefore, teaches a method of usingalternate pad materials in order to obtain the optimum system forcollection and subsequent testing or analysis of certain hormones, drugsand any materials likely to cause difficulty in analyte removal from thepad. The ability to provide flexible options for pad materials is anovel invention. An advantage of this is that the pad material may bemodified and optimized to suit the subsequent analysis, testing, orother action to be performed.

As shown in FIG. 1 a, pad compression tube 20 may include locking holes34 located on the opposing faces of handle 14 to engage locking teeth 32which are located on the corresponding opposing faces of pad compressiontube 20. Teeth 32 are preferably unidirectional to allow pad compressiontube 20 to slide easily onto handle 14 but prevent removal. Lockingteeth 32 are sloped away from outlet ports 22 to facilitate insertinginto compression tube 20. Locking holes 34 are spaced along the lengthof pad compression tube 20 to allow pad compression tube 20 to lock inprogressively tighter positions. In operation, locking holes 34 engagelocking teeth 32 to ensure absorbent pad(s) 15 remain compressed toprovide adequate liquid sample is separated for retention and testing,and prevents inadvertent reuse to inhibit spread of infectious diseases.Locking holes 34 also provide an air escape path to allow fullcompression of absorbent pad 15 without forcing liquid sample back intothe cavity of handle 14.

In an alternative embodiment, as shown in FIGS. 11, 12, absorbent padcan be a folded in half providing a double layer absorbent pad toprovide additional structure for the absorbent pad and increase thesurface area and absorption volume. FIG. 11 at 200 shows one possibleshape, with the pad folded upon itself along the fold line at 202, whichcan be used with the specimen sample collective device 10. FIG. 12 at204 shows a split absorbent pad shape, with the pad folded upon itselfalong the fold line at 206.

As shown in FIGS. 2-4, sufficiency indicator may be a shaped light pipe18 with a color or indicator on one end 18 a, which is placed in contactwith the absorbent pad 15. It is preferably made of styrolux. As show inFIG. 3, when the absorbent pad 15 is saturated with saliva, therefractive properties of the boundary layer between light pipe 18 andabsorbent pad 15 change causing more light to pass through the boundaryrather than refracting upward. This is visualized by the user asaltering the visibility of the indicator, which is seen as a line 18 b.

As shown in FIG. 3 a, a sufficiency indicator with a light pipe mayinclude a spring compressor 30. Spring compressor 30 is shaped toconform to the profile of light pipe 18, thereby assuring continuouscontact between absorbent pad 15 and light pipe 18 along their boundaryto ensure saturation of absorbent pad 15 alters the refractiveproperties of the boundary. Using a spring compressor also permitseasier manufacture of handle 14, which does not have to be shaped toconform to the contours of light pipe 18.

Alternatively, the sufficiency indicator can be a molded or otherwisemanufactured window, convex side downward, and frosted or textured suchthat when absorbent pad expands by absorption of sufficient sample, thewet absorbent pad touches the inside of the indicator resulting in achange in window clarity, clear spot or symbol indicating that adequatesample volume has been achieved. In this embodiment, an expandablematerial in contact with an absorbent pad, expands behind and obscuresan indicator providing a visual indication that sample volume isadequate when an adequate sample content is reached.

Alternatively, the sufficiency indicator can be a clear window with asmall absorbent pad with a colored dot on the inward side, attached onthe inside of the window. When the absorbent pad expands against theabsorbent paper, the liquid from that pad is transferred to theabsorbent paper. Becoming wet, the absorbent pad becomes translucentduring which time the colored dot becomes visible through the absorbentpaper and becomes visible in the sample adequacy indicator.

Alternatively, the sufficiency indicator can be coated on the insidewith a chemically neutral hydrochromic material such that when absorbentpad swells with sample it absorbs, the swollen pad touches the inside ofthe indicator, reacting with the coating and causing a color change orgraphic symbol to appear. Those skilled in the art know that manydifferent chemically neutral hydrochromic coating materials can be usedwhich would not alter the test samples.

Alternatively, the sufficiency indicator is a simple Liquid CrystalDisplay (LCD) device with two bi polar metal leads pressing into theabsorbent pad. When the pad is of adequate saturation, galvanic actioncauses a small electrical current to flow between the metal leadscausing the LCD to darken.

Alternatively, the sufficiency indicator may be configured as a snapindicator that includes a plastic spring 370 set in a sponge 372 asshown in FIG. 13. Spring 370 is a strip of plastic (or other semi-rigidmaterial such as thin metal) acting as a leaf spring when bent. In anembodiment, a spring 370 is anchored at one end 374 and bent so thenon-anchored end 376 is retained by sponge 372 which loses rigidity whenwetted. Spring 370 may have an indicator (a color marking or symbol foreasy visibility) applied to non-anchored end 376. Sponge 372 is mountedin contact with absorbent pad 315, and sample adequacy indicator window318 is located above the non-anchored end 376 of spring 370, embedded inhandle 314. When absorbent pad 315 absorbs sufficient saliva, asdetermined by the manufacturer based on the tests to be conducted andthe need for retaining verification samples, some of that liquid istransferred to sponge 370 causing it to lose rigidity. When sponge 370is saturated with saliva the non-anchored end 376 of spring 370 releasesand snaps against the inside of sample adequacy indicator window 318providing an audible indication that sufficient sample volume has beenreached, and spring 370 remains in that position to provide visualconfirmation as well. If non-anchored end 376 is marked this markingwill be visible through sample adequacy indicator window 318 to aid theobserver.

Sponge 372 can be cellulose, open cell foam or a similar material thatwhen moistened loses structural rigidity and softens. Sponge 372 mayalso be a material which dissociates or dissolves when wetted, such asunfired ceramic, clay, salt crystals or sugar crystals. Therefore, inthis embodiment the term “sponge” refers to either an actual sponge, orto any material which loses its structural rigidity when wetted.

Fluids are removed from absorbent pads by squeezing sample from the padmaterial through compression tubes. Alternate methods of fluid removalmay be envisaged as necessary to facilitate removal of said liquid fromthe pad. Such techniques include vortexing, squeezing, centrifugationand treatment with an agent to promote removal of non-constituentcomponents of the pad material among others. Pushing the handle into thepad compression tube compresses the absorbent pad expelling specimenfrom absorbent pad into the pad compression tube. As shown in FIG. 7,pad compression tube 20 when inserted over absorbent pad 15 and one endof handle 14 is in fluid communication with absorbent pad 15.

Pad compression tube 20 can have one or more channels and one or moreoutlets. FIG. 8 shows a dual outlet dual channel pad compression tube120 having two outlets 122 a, 122 b. FIG. 9 shows a single outlet singlechannel pad compression tube 150 with a single outlet 152. FIGS. 1, 5 a,5 b, 5 c, and 7 show a dual outlet single channel pad compression tube20 with two outlets 22 a, 22 b.

As seen in FIG. 7, pad compression tube 20 fits over and around theabsorbent pad 15, which is partially contained within the handle 14 (seealso FIG. 10), and tube 20 goes over the end of the handle 14. As shownin the embodiment in FIG. 8, handle 114 can be provided with a ridgedlock 160 which fits in a depressed key 162 on a pad compression tube120. Absorbent pad 115 is pushed into pad compression tube until“locked” into place for safety preventing contamination and infectioustransfer.

Pad compression tubes are is made of polypropylene or acrylic or othersuitable material. Pad compression tubes can be provided with a tubecap, see 24 in FIG. 1 made of polypropylene or other suitable material.

A dual outlet dual channel pad compression tube 120 fits around a splitabsorbent pad 115. Pushing the handle 114 into the dual outlet dualchannel pad compression tube 120 compresses the split absorbent pad 115,expelling specimen from split absorbent pad 115 into the dual outletdual channel pad compression tube 120. Dual outlet dual channel padcompression tube 120 when inserted over split absorbent pad 115 and onend of handle 114 is in fluid communication with split absorbent pad115. As shown in FIG. 8, the dual outlet dual channel pad compressiontube 120 includes a structural barrier 140 hat separates the two partsof the split absorbent pad 115, such that when the pad 115 is compressedupon entry into the compression tube 120, the saliva sample from eachsaid part of the pad 115 remains distinct and separate. Next, eachseparated saliva sample flows or is compressed into its ownEppendorf-style collection tube 126, which is attached to a compressiontube, see 120 in FIG. 8 and 150 in FIG. 9.

As shown in FIG. 14, in another embodiment a specimen sample collectiondevice and test system 412 may include a large absorbent pad 415 a and asmall absorbent pad 415 b in parallel with one another within handle414. In this case “large” and “small” refer to the volume of liquidsample absorbed and not necessarily to the physical dimensions. Largeabsorbent pad 415 a is in fluid contact with sample adequacy indicator418, but not in fluid communication with lateral flow test strip 416.The size of large absorbent pad 415 a is determined by the desired sizeof sample to be retained for verification or separate analyses. Smallabsorbent pad 415 b is in parallel with large absorbent pad 415 a and influid contact with test one or lateral flow test strips 416, but not influid contact with sample adequacy indicator 418. In FIG. 14 largeabsorbent pad 415 a and small absorbent pad 415 b are positioned inparallel with one above the other, but not in fluid contact with oneanother. The absorbent pads may be separated by a small gap or by animpermeable membrane 480. Alternatively, large absorbent pad 415 a andsmall absorbent pad 415 b may be aligned side-by-side. Rapid results maybe viewed through viewing window 460.

In use, both large absorbent pad 415 a and small absorbent pad 415 b areplaced in a patient's mouth simultaneously, preferably under the tongue,until the sample adequacy indicator 418 is triggered indicatingsufficient volume of saliva has been collected. Immediate test resultsmay be observed through the test strip viewing window 460. Parallelabsorbent pads with separate test strips and adequacy indicator reducethe time required to obtain both immediate test results and adequatevolume for retained liquid specimens. Each pad's dimensions can beoptimized for its function. Large and small absorbent pads 415 a & b maybe of differing absorption characteristics which are optimized for theparticular testing regime. Large absorbent pad 415 a may be optimizedfor maximum absorption volume while small absorbent pad 415 b may beoptimized for transferring maximum volume of liquid sample to test strip416. The length of the test strips and the overall length of thespecimen sample collector 412 can be reduced as well.

The pad compression tube outlets can also each contain a particulatefilter (not shown). Each distinct and separate saliva sample can passthrough its own particulate filter remaining distinct and separate.

The pad compression tube can contain a buffer solution to stabilize thesample obtained for analysis or testing. Suitable buffers include anaqueous solution with any of a variety of salts including sodiumchloride, sodium phosphate, ethylene diamine tetra acetic acid (EDTA)salts or others. Buffer solution may contain a preservative to maintainthe integrity of the sample and minimize degradation. This preservativeserves to inhibit proteolytic properties of enzyme materials that cancause destruction of the antibody molecules being tested with the deviceover time. The types of compounds that can be considered as conferringpreservative properties include enzyme inhibitors, anti-bacterialagents, bacteriostatic molecules, and anti-fungal compounds amongothers. Within the sub-group of bacteriostatic molecules, there are anumber which can be added to also inhibit the growth of microorganisms.Such compounds include ProClin® (in various formulations) sodium azideand thimerosal.

The buffer solution may also include a detergent material, whichimproves antibody removal from the absorbent pad material, when desired.Preferred examples of this are Tween-20 (chemical name polyoxyethylenesorbitan monooleate) and sodium dodecyl sulfate (SDS), although otherexamples, e.g. Triton X-100, chlorhexidine and others may also be used.Tween-20 for example, is also useful for prevention of non-specificbinding of required antibody molecules to unwanted solid surfaces.Typical concentrations of Tween-20, for instance, necessary to achievethe desired effect, range from 0.1%-1%. Similarly, low molecular weightalcohols (ethanol, methanol, butanol, etc.) in low concentrations(0.1-4.0%) can be introduced as additional analyte-releasing agents,depending upon the material under investigation.

Those skilled in the art will know that there are many possible agentscapable of being used as “buffering components”. Alternately the padcollection tube may contain no reagent or liquid whatsoever.Alternately, the pad collection tube may contain a non-fluid containingbuffer, i.e. a buffer without liquid, commonly referred to as a “drybuffer”. The permutation and concentrations of any agents used as partof the collection procedure will be optimized for the collection ofspecific target molecules. In the case of analytes or materials that aredifficult to release from the pad material under “normal” bufferconditions, for example “sticky” materials such as the drug THC, orsteroid hormones (including testosterone, estradiol, progesterone andothers), various reagents including small quantities (less than 5%) ofan alcohol, e.g. methanol, ethanol, propanol, iso-propanol may be addedto facilitate analyte release.

Typical buffers include phosphate buffered saline consisting of, forexample: 10 mmol/L Sodium Phosphate Dibasic; 150 mmol/L Sodium Chloride;5 mmol/L Disodium Ethylenediamine Tetraacetate (EDTA); 31 mmol/L SodiumAzide; Adjusted to neutral pH of 7.2.

Collection tubes can be a chambered collection tube 26, as shown inFIGS. 1, 6 a, 6 b, and 6 c, or individual collection tubes 126, as shownin FIGS. 8 and 9.

Chambered collection tube 26 is shown in different views in FIGS. 6 a, 6b, 6 c. Collection tubes fit over the end of the pad compression tubeand have one or more chambers for receiving and holding collectedsamples. These chambers or compartments are separated allowing samplesto remain distinct and free from contamination. In an embodiment,collection tube, at 26 in FIG. 1 and at 126 in FIGS. 8 and 9, wheninserted on end of pad compression tube, 20 in FIG. 1, 120 in FIG. 8,and 150 in FIG. 9 is in fluid communication with pad compression tube.Collection tube, at 26 in FIG. 1 and at 126 in FIGS. 8 and 9, can beprovided with a tube cap, at 28 in FIG. 1, and at 128 in FIGS. 8 and 9,sealing the tubes.

Eppendorf-type collection tubes 126, in FIGS. 8 and 9, collect theseparate and distinct saliva samples once they pass through a padcompression tube. Eppendorf-type collection tubes 126 are conical attheir closed end, round at the open end, and comprised of flexible lids128 that remain attached to the tube 126 whether open or closed. TheEppendorf-type collection tubes 126 may be attached together on theoutside surface. The Eppendorf-type collection tubes 126 remain inwardlydistinct in that each receives one of the distinct and separate salivasamples and said samples remain separate and distinct once in theEppendorf-type collection tubes 126. The Eppendorf-type collection tubelid 128 is then closed, retaining the fluid sample's integrity andquantity.

Handles, pad compression tubes, and collection tube can be made usingany number of different processes familiar to those with skill in theart, such as by injection molding, compression molding, casting;incorporating materials such as thermoplastics, thermosets, glass,metal, etc. The light pipe indicator window can be made of clearmaterial, e.g. glass, plastic, or Perspex.

In a preferred embodiment, handle 14 is assembled from two elongatedpieces of General Purpose Styrene 14 a & b which snap together over aportion of the absorbent pad. See FIG. 10. The two halves of handle 14are then sealed together using ultrasonic welding methods. Those ofskill in the art know that the handle can be made of any one of numerousmaterials.

In a preferred embodiment the apparatus is intended for collectingsaliva, though other embodiments for collecting samples other thansaliva exist (such as collection of water for environmental testingpurposes, urine analysis for drug testing, bioavailability testing inthe pharmaceutical industry and many others), absorbent pad is placed inthe mouth under the tongue. Absorbent pad expands when a specimen sampleis received. When indicator indicates sufficient sample has beenobtained, Indicator provides a visual indication of the same.

In order to enrich the specimen with immunoglobulins, which are presentunder the lip line at the end of the collection process, the specimensample collection device is taken and “swabbed” once across the gumsfrom one side to the other, then reversed and swabbed across the gumline a second time in the opposite direction.

In order to collect saliva, the specimen sample collection device isplaced under the tongue and allowed to remain there until the visualindicator in the device—a light pipe showing a bluecoloration-disappears completely. The typical collection time for sampleadequacy is in the range of 1-2 minutes. The sample adequacy indicatormay be observed by a second person or in the event of the sample beingcollected in the privacy of the home, by a donor in isolation. Thedevice may be removed from the mouth to visually inspect for adequatesample volume and replaced under the tongue immediately withoutdetriment to the collection or subsequent test procedure.

In operation using a split absorbent pad 115 and a dual outlet dualchannel pad compression tube 120, the user places the pad 115 into thedual outlet pad compression tube 115 with the split end facingdownwards, and places the Eppendorf-type collection tube 126 on theoutlets 122 of the dual outlet pad compression tube 120, and pushes onhandle 114, forcing the pad 115 all the way down to the bottom of thecompression tube 120 until the end of the handle 114 can be pushed nocloser to the bottom of the compression tube 120. Pushing expelsspecimen from split absorbent pad 115, which then travels in fluidcommunication through the dual outlet pad compression tube 120, throughthe outlets 122 and into collection tubes 126. The collection tubes 126thus provide samples for supplemental or confirmatory testing as well asfor independent storage or transportation. Two samples are thusprovided. Depending upon the dimensions and type of pad material usedthe individual forks of the absorbent material will release between 0.3ml and 2 ml of pure saliva. In instances where the individual samples,are to be transported to a laboratory or remote location, or are not forimmediate testing, a preservative buffer may be introduced either in thecompression tube or the collection receptacles to maintain the integrityof the sample so collected. The buffer may be a liquid or dry buffer. Ininstances where the samples are to be tested immediately, or at thepoint-of-care, the device may be supplied without buffer. In order todetermine the volume of specimen received by this action, graduatedtubes, such as small Eppendorf tubes, available “off the shelf” from anumber of vendors, may be used. Alternatively, where no duplicatesampling is required, the collection tube can be a single channelcollection receptacle or Eppendorf tube. Depending upon samplingrequirements alternative customized collection tubes may be adapted foruse with the invention. Each of the tubes used in connection with thecollection tool are fitted with individual caps for sealing purposes.These caps may be tamper-proof for evidentiary purposes. Similarly, thepad compression tube can be provided with a cap or caps for sealing.

As shown in FIG. 10, the specimen sample collection device 10 can beprovided with one or more lateral flow test strips 16 a, 16 b in thehandle 14 in fluid communication with the absorbent pad 15 by one ormore membranes 17 a, 17 b. Such tests strips, for example ICT strips arecommonly used in the diagnostic industry today, to screen for a plethoraof diseases including HIV, streptococcus A & B, hepatitis A, B & C,cardiac markers (e.g. troponin 1, troponin T, myoglobin), tumor markers(e.g. prostate specific antigen (PSA), alpha-fetoprotein (AFP), etc.),glucose, cholesterol and others.

The test strip is coated or “striped” with one or more analyte ofinterest, together with a control material usually Protein A-gold coatedto human IgG to verify that the test strip is working appropriately.Such strips are now very commonly available and well characterized.After a short period of time (which may vary from 2 to 20 minutes), aControl Line will appear on the test strip, and in instances of apositive specimen a second line (the Test Line) will appear indicatingpositivity for the analyte of interest.

The test strip is comprised of reagents that test qualitatively (for thepresence or absence of analytes or substances) and/orsemi-quantitatively (providing an estimate of the quantity) of thechemical(s)/substances for which the device tests within the fluidsample. In an embodiment the test strip is located in the collectorhandle housing, above the attachment loci of the absorbent pad. Thecollector handle housing has a window-type opening above a portion ofthe test strip through which results from the test strip can be viewed.

A reagent test strip comprised of at least one reagent chemical thatupon contact with the chemical for which it tests or a by-product of thechemical for which it tests in the testing fluid, undergoes a chemicalreaction which produces or activates an indicator, preferably visual, ofthe presence or absence and/or quantity of the chemical for which ittests.

The test system may be applied to a number of different diseases, andanalytical tests, which includes HIV, drugs of abuse, bacteria, viruses,environmental toxins and others. Reaction times and run times will varydepending upon the characteristics of individual test strips, which areoptimized to achieved maximum sensitivity and specificity. Thecharacteristics of each individual test will be defined in therespective package insert for the products, however, as an example, anHIV test optimized for oral fluid detection using the specimen samplecollection device will provide results within a period of 10-20 minuteswith a sensitivity greater than 95% and a specificity of greater than99%. What should be understood in the case of an HIV test is that theappearance of a Test Line in the presence of a Control Line isindicative of an initially positive or non-negative result.

When more than one test strip is provided they are arranged side-by-sideon the handle 14, as shown in FIGS. 4 and 10, at 16 a, 16 b. In thisembodiment, saliva collected in identical fashion to the embodimentsdescribed above, is transferred to two test strips instead of one by twomembranes, 17 a, 17 b. Using this configuration, a multiplicity ofanalytes, for instance drugs of abuse, including but not limited to theNIDA-5 series of drugs, benzodiazepines, Oxycodone, and others, as wellas therapeutic drugs and multiple infectious diseases for instance maybe detected simultaneously using a single oral fluid collection deviceand test system. Test strips for the NIDA-5 series of drugs have beenoptimized in the specimen sample collection device to run within 15minutes from the time sample adequacy has been achieved.

In this embodiment, the reagent test strips 16 are located in thecollector handle 14 housing with a window-type opening 60 above eachtest strip 16, or, alternatively, a single window-type opening above allthe test strips. Each test strip contains a reagent test for analyzingthe qualitative (presence or absence) and/or quantitative data of thechemical for which it tests within the fluid sample. One of skill in theart would understand that each test strip may test for a differentchemical or the same chemical as any other test strip. In an embodiment,the test strips extend linearly down the length of the collector handlehousing, parallel to one another. In another embodiment, the test stripsmay be adjacent to one, two or more additional test strips.

In embodiments including a test strip 16 under a test strip opening 60,the results may be read visually or may be read by electronic readingdevices including pocket-PC devices, PDAs and others. In a preferredembodiment of this invention a pocket-PC driven system, utilizesproprietary software to digitally record images from the lateral flowtest strips. The reader combines a “Pocket PC” (PDA-sized) readingsystem, printing device, camera and software, capable of readingmultiple lines within a pre-set reading window. Once the specimen samplecollection device incorporating one or more test strips has run and theimmunochromatographic test results have been observed visually, (afterthe pre-established reaction time is over), a plastic cap is placed overthe absorbent collection pad of the specimen sample collection device,if desired, then the opposite end of the device (handle-first) isinserted into the port of the hand-held reading device. The readingdevice initially does a diagnostic “self test” to ensure that the readeris working appropriately then performs a read out of the intensity ofthe coloration of the individual line (or lines) on the test strip (orstrips). The results of this are fed automatically to a printing device,which prints out a permanent record of the results for each drug orother analyte being tested. The visual appearance of a line, or theconfirmation of a line in the case of drug tests using the hand-heldreading system is an indication that the test is negative ornon-positive for that particular analyte or drug. This is the oppositeof what one would find for similar tests for HIV and other analyteswhere the presence of a Test Line in the presence of a Control Line isindicative of a positive or non-negative result. The invention providesvisually read, qualitative results, which may be quantified usingavailable electronic, digital or other format readers. These in turn maybe either small, PDA-sized (hand-held) systems or portable and nonportable instruments that utilize electromagnetic radiation,chemiluminescence, digital photography and other techniques, whileproviding a digital printout of the quantitative results obtained.

Fluid forced through separate porous filters in pad compression tube andinto mutually distinct graduated Eppendorf-type tubes attached to thepad compression tube outlets. Each Eppendorf tube is then bar coded. Abar code may further be provided on the specimen sample collectiondevice handle. A recess is molded into the specimen sample collectiondevice handle and the bar code is imprinted thereon.

Referring to FIGS. 15-17, in another embodiment, a specimen samplecollection device 510 includes a handle 514 with a sufficiencyindicator, such as a light pipe indicator window 518, and an absorbentpad, which can be a rounded tongue split absorbent pad 515, a collectordam 570, a pad compression tube 520, and a collection tube 526. Specimenhandle 514 may be manufactured in two parts 514 a and 514 b for ease ofassembly. Specimen handle 514 includes gripping teeth 542 to holdabsorbent pad 515 in place.

Specimen handle 514 includes locking teeth 532 on opposing sides ofspecimen handle 514 for engaging locking holes 534 on pad compressiontube 520. Locking teeth 532 engaging locking holes 534 assist in keepingspecimen handle 514 aligned within pad compression tube 520 duringcompression so that collector dam 570 may more effectively seal againstbackflow. Preferably specimen handle 514 also includes ridge 580encircling specimen handle 514, which also aids in alignment of specimenhandle 514 in pad compression tube 520. Alternatively, locking holes 534may consist of detents along the interior wall of pad compression tube520 which do not penetrate through the wall but are able to engagelocking teeth 532. Absorbent pad 515 fits partially within the handle514. Absorbent pad 515 can be split as shown in FIGS. 15-17. Alternativeabsorbent pad materials may be used in order to optimize the collectorfor specific analytes, proteins, or other chemicals.

Referring to FIGS. 15-17, pad compression tube 520 can include a padseat 590 interposed at the pad compression tube outlet 522. Preferablypad seat 590 is made from the same material as absorbent pad 515 so asto have the same stickiness properties as absorbent pad 515. Pad seat590 is impregnated with buffer material which becomes mixed with theliquid sample as liquid sample is compressed out of absorbent pad 515within pad compression tube 520 and expressed through outlet 522 intocollection tube 526. Preferably collection tube 526 is an Eppendorfcollection tube. In this way, the buffer carried through will helppreserve the oral fluid specimens until they reach the laboratory forsubsequent testing.

Pad seat 590 can be impregnated with buffer material utilizing severalmethods. In a first method, liquid buffer is sprayed onto pad seat 515.This first method is difficult to ensure even application and propersaturation of pad seat 590, and the liquid buffer is less stable andconsequently has shorter shelf life. However, the first method iseffective where long shelf life is not a concern. Where the first methodwith liquid buffer spray is utilized, the pad seat 590 must be speciallypackaged to prevent drying out.

In a second method, liquid buffer solution is first lyophilized (i.e.freeze dried) and then applied to pad seat 590 by dry spray methods.Lyophilization provides for better buffer stability for long termstorage and wider temperature conditions, an important consideration forfield applications.

In a third method, pad seat 590 is saturated in liquid buffer solutionand then the saturated pad seat 590 is dried through lyophilization.This method provides reliable saturation and maximizes stability andshelf life with the dry buffer.

Referring to FIGS. 15-17, a collector dam 570 is shown. Collector dam570 is preferably a flat silicone rubber sheet with a first flap 572 anda second flap 574 defining an opening 576 for receiving an absorbent pad515. Collector dam 570 has a perimeter edge 578 with a cross-sectionmatching the interior cross-section of pad compression tube 520. Theperimeter edge 578 of collector dam 570 seals against the interior wallsof pad compression tube 520 as specimen collector 512 is pushed into padcompression tube 520 to expel liquid sample into sample collection tube526. First and second dam posts 540 a & b projecting from collectorhandle 514 assist in maintaining alignment for collector dam 570 duringcompression. Collector dam first and second flaps 572 and 574 acttogether as a pinch valve on absorbent pad 515. Collector dam first andsecond flaps 572 and 574, respectively, are normally oriented outwardly,as shown in FIGS. 16 & 17. In this orientation they only loosely gripabsorbent pad 515 so as to not prevent liquid wicking along absorbentpad 515 to sufficiency indicator 518. As absorbent pad 515 is compressedagainst the outlet wall 520 a of pad compression tube 520, absorbent pad515 is urged rearwards into specimen handle 514. The rearward pressureof absorbent pad 515 causes collector dam first and second flaps 572 and574 to close against each other, thereby pinching off opening 576 andsealing against backflow along absorbent pad 515 into specimen collectorhandle 514. With first and second flaps 572 and 574 sealing againstbackflow through absorbent pad 515, and perimeter edge 578 sealingagainst the interior walls of pad compression tube 520 to preventbackflow around the edges, a plunger effect is created. The sealscreated by first and second flaps 572 and 574, and perimeter edge 578,allow greater pressure buildup to express liquid sample through theoutlet port 522 of pad compression tube 520. Greater volume of liquidsample can be recovered using collector dam 570. Preferably collectordam 570 is made from silicone rubber due to its wide chemicalcompatibility, impermeability, flexibility and low cost. Preferablycollector dam 570 is die-cut from silicone rubber sheet material ofapproximately 1/16 inch sheet thickness.

As shown in FIGS. 15-17, alignment flange 580 is provided to assist inaligning collector handle 514 within pad compression tube 520 during padcompression. Alignment flange 580 may alternatively incorporate ano-ring to provide a secondary seal during compression of absorbent pad515 in pad compression tube 520.

Collector dam 570 can be used with multi-pad collector devices byproviding individual openings for each pad.

Collector dam 570 and secondary seal 580 provide increased safety tomedical staff as well as improved efficiency in sample collection.Collector dam 570 and secondary seal 580 prevent liquid saliva fromsquirting backwards out of pad compression tube 520 on the user, aconcern for highly contagious patients. This is an especial concern whenutilizing porous frits or other filters in the outlet of pad compressiontube 520, as these devices increase the back pressure while expressingliquid sample out of pad compression tube 520.

Referring to FIG. 18, in an exploded view, an embodiment of specimensample collection device 512 includes a collector handle 514 comprisingfirst and second collector handle parts 514 a and 514 b, light tubesufficiency indicator 518 within collector handle 514, collector dam570, a single tongue absorbent pad 518 a, pad seat 590 made from thesame material as absorbent pad 518 a, pad compression tube 520 with asingle outlet port 522, and collection tube 526 insertable onto outletport 522.

Referring to FIGS. 19-21, another embodiment of a specimen samplecollection device and test system 612 is shown, including a samplecollection device 610, pad compression tube 620, and collection tube(not shown) for attaching to the outlet 622 of pad compression tube 620.Sample collection device 610 includes round cylindrical absorbent pad615 which inserts into collector handle 614, plunger 670, and samplevolume adequacy indicator 618. Collector handle 614 preferably includesa finger grip 614 a.

The round cylindrical shape of absorbent pad 615 provides efficientvolume for collection of liquid saliva sample, and provides more uniformcompression characteristics than traditional flat absorbent pads.Absorbent pad 615 includes a narrow extension which extends intocollector hand 614 for attachment, as well as providing a wickingchannel which maintains contact with adequacy indicator 618.

Plunger 670 includes a first flange seal 678 for sealing against theinner wall of pad compression tube 620 as absorbent pad 615 iscompressed to express liquid sample. Preferably second flange seal 680is provided, spaced apart from first flange seal 678 along the axiallength of collector handle 614. Second flange seal 680 provides asecondary seal as well as aiding in maintaining alignment of samplecollector 610 as it is inserted into pad compression tube 620.Preferably pad compression tube 620 includes a pad seat with buffermaterial such that buffer material is mixed with liquid sample as theliquid sample is expressed through pad compression tube outlet 622.

Sample adequacy indicator 618 is preferably a wrap-around light pipe. Asshown in FIGS. 19 & 20, light pipe 618 includes a first surface 618 awhich is aligned normal to the long axis of collector handle 614, and asecond surface 618 b at an angle of incidence to 618 a. First surface618 a is provided with a color coating or a pattern, and second surface618 b provides visual indication to the user of saturation by alterationof the refraction characteristics. Absorbent pad 615 is in physicalcontact with second surface 618 b. With absorbent pad 615 dry, or atleast not saturated all the way to the region of light pipe 618, lightreflected from first surface 618 a is refracted radially outward whenencountering second surface 618 b, so that a user sees a colored orpatterned band at second surface 618 b. When absorbent pad 615 becomessaturated with liquid sample to the region of light pipe 618, therefractive characteristics of the boundary between second surface 618 band absorbent pad 615 (now saturated with liquid) alter so that lesslight is refracted at the boundary and more light is transmitted throughthe boundary, such that the colored or patterned band is no longervisible.

Referring to FIG. 20, wrap-around light pipe 618 is substantiallyannular in shape and includes a plurality of narrow ventilation grooves619 a-c aligned axially along the inner surface 618 c of light pipe 618in fluid communication with the interior annulus of wrap-around lightpipe 618 and the exposed portion 615 a of pad 615 which extends out ofhandle 614. Preferably wrap-around light pipe 618 includes threeventilation grooves 619 a-c disposed symmetrically around the innersurface 618 c of light pipe 618. Each of ventilation grooves 619 a-cextend nearly the length of light pipe 618, from a first end disposedbetween light pipe first surface 618 a and second surface 618 b,extending under plunger 670 to the exposed portion 615 a of absorbentpad 615. As absorbent pad 615 wicks liquid sample past plunger 670, theair within absorbent pad 615 is displaced by the liquid, requiring avent path to prevent pressure buildup which would inhibit the absorptionprocess. Ventilation grooves 619 a-c allow air displaced from absorbentpad 615 to flow out past plunger 670, but do not interfere with the sealbetween first and second sealing flanges 678 and 680 and the inner wallof pad compression tube 620.

Other sample volume adequacy indicators could also be compatible withthis embodiment, as described above. Wrap-around light pipe 618 hasseveral additional advantages. The light pipe avoids potentialcontamination of liquid samples in devices using dilution or migrationof dyes for adequacy indication. The light pipe is easily manufacturedfrom plastic and easily assembled with the device. The light pipe andthe wrap-around light pipe are easily sealed so as to provide efficientcompression and expression of liquid sample using pad compression tube620. The wrap-around light pipe allows the medical technician to observethe sampling in real time, so there is no need to remove the samplecollector from the patient's mouth to check the adequacy indicator,thereby avoiding potential contamination problems. The light pipeprovides a clear go/no-go indicator of sample adequacy, whereas devicesusing dilution or migration of dyes require some interpretation andguess work by the user.

The embodiments of the present invention are compatible with a varietyof absorbent pad materials, which can be interchanged depending on thetargeted analytes, proteins or chemicals. The use of non-detachingabsorbent pads in combination with pad compression tubes provides forsimplified and more reliable testing procedures. The absorbent paditself is more securely held in the sample collection device. There isno danger of dropping the absorbent pad while trying to detach the padand insert it into a buffer solution, which would contaminate the sampleand which poses a contagion hazard. There is no requirement tocentrifuge the absorbent pad to remove liquid sample. The absorbent padcompressed and locked into the pad compression tube can still bepreserved for future verification testing, and the pad compression tubeor handle are more easily labeled with sample identifier information.The sample collection and test system as described herein issubstantially “idiot-proof”, preventing inadvertent mistakes by poorlytrained field personnel (who might not have any medical training at all)working in harsh climates and unsanitary environments, which couldrender samples unusable or spread disease.

Referring to FIGS. 19 and 21, a saliva sample collection device and testsystem is provided with an aesthetically pleasing design, including arounded handle shape to match the absorbent pad 615, plunger 670, andsample sufficiency indicator 618, soft curves and transitions, and aclean, proportional overall look.

Those skilled in the art will recognize that numerous modifications andchanges may be made to preferred embodiments without departing from thescope of the claimed invention. It will, of course, be understood thatmodifications of the invention, in its various aspects, will be apparentto those skilled in the art, some being apparent only after study,others being matters of routine mechanical, chemical and electronicdesign. No single feature, function or property of a preferredembodiment is essential. Other embodiments are possible, their specificdesigns depending upon the particular application. As such, the scope ofthe invention should not be limited by the particular embodiments hereindescribed but should be defined only by the appended claims andequivalents thereof.

1. A specimen sample collection device and test system, comprising: ahandle including a sufficiency indicator and means for providing a watertight seal between said handle and a pad compression tube insertableover said handle; an absorbent pad partially contained within saidhandle, said absorbent pad comprising round cylindrical shape; a padcompression tube insertable over said absorbent pad within said handleand around an end of said handle, said pad compression tube includingone or more outlet ports; and, one or more collection tubes having oneor more sample chambers, attachable to said one or more pad compressiontube outlet ports, and wherein said compression tube defines one or morechambers in fluid communication with said one or more pad compressiontube outlet ports, and wherein when said collection tube is attached tosaid one or more pad compression tube outlet ports, the chambers are influid communication with said pad compression tube; wherein saidsufficiency indicator is a wrap-around light pipe of substantiallyannular shape and a portion of said absorbent pad extends into theannulus of said wrap-around light pipe, said light pipe including afirst end surface with a marking and a second surface in physicalcontact with said absorbent pad creating a refractive boundary, saidsecond surface oriented at an angle of incidence to said first surfacesuch that when the absorbent pad absorbs a sufficient liquid sample therefractive properties of said boundary alter the observability of themark.
 2. The system of claim 1, wherein said means for providing awatertight seal comprises a plunger, said plunger being substantiallyannular and disposed over an end of said handle for receiving saidabsorbent pad through the center of said plunger.
 3. The system of claim2, wherein said plunger includes first and second flange seals at distalends of said plunger for sealing against the interior of said padcompression tube.
 4. The system of claim 1, wherein said wrap-aroundlight pipe extends through the interior annulus of said sealing means,and wherein said wrap-around light pipe includes a plurality of interioraxial grooves extending substantially the length of said wrap-aroundlight pipe, said grooves in fluid communication with a portion of saidabsorbent pad not contained within said handle and with a portion ofsaid absorbent pad extending into the annulus of said wrap-around lightpipe.
 5. The system of claim 1, further comprising a pad seat, said padseat disposed within said pad compression tube proximally to said padcompression tube outlet ports, wherein said pad seat contains buffermaterial.
 6. The system of claim 5, wherein said pad seat buffermaterial comprises a wetted solution.
 7. The system of claim 5, whereinsaid pad seat buffer material comprises a lyophilized buffer materialapplied to said pad seat in a dry condition.
 8. The system of claim 5,wherein said pad seat buffer material comprises a lyophilized buffermaterial applied to said pad seat in a wet condition, and wherein saidpad seat including said wet buffer solution is lyophilized.
 9. Aspecimen sample collection system, comprising: a handle including asufficiency indicator and a plunger; an absorbent pad partiallycontained within said handle to absorb a fluid sample, the absorbent padhaving a round cylindrical shape; a pad compression tube including oneor more outlet ports, the pad compression tube to receive at least theabsorbent pad and the plunger, the plunger to provide a water tight sealbetween the handle and the pad compression tube; wherein saidsufficiency indicator is a wrap-around light pipe of substantiallyannular shape and a portion of said absorbent pad extends into theannulus of said wrap-around light pipe to indicate a sufficiency of thefluid sample.
 10. The system of claim 9, the wrap-around light pipefurther comprising a first end surface having a marking and a secondsurface in physical contact with the absorbent pad to create arefractive boundary, the second surface oriented at an angle ofincidence to the first surface such that when the absorbent pad absorbsthe sufficient fluid sample the refractive properties of the refractiveboundary alter the observability of the mark to indicate collection ofthe sufficient fluid sample.
 11. The system of claim 9 furthercomprising one or more collection tubes each having one or more samplechambers, the one or more collection tubes to couple to the one or morepad compression tube outlet ports, the one or more collection tubes toreceive the fluid sample from the absorbent pad when the absorbent padis compressed in the pad compression tube.
 12. The system of claim 9,the plunger further comprising a first flange seal and a second flangeseal at distal ends of the plunger to seal against the interior of thepad compression tube when the absorbent pad and the plunger are insertedinto the pad compression tube.
 13. The system of claim 9, thewrap-around light pipe further comprising a plurality of interior axialgrooves extending substantially the length of the wrap-around lightpipe, the axial grooves in fluid communication with at least a portionof the absorbent pad not contained within said handle and with a portionof the absorbent pad extending into the annulus of the wrap-around lightpipe.
 14. The system of claim 9 further comprising a pad seat, the padseat disposed within the pad compression tube proximate to the one ormore pad compression tube outlet ports, the pad seat further including abuffer material.
 15. The system of claim 14, the pad seat buffermaterial further comprising a wetted solution.
 16. The system of claim14, the pad seat buffer material further comprising a lyophilized buffermaterial applied to the pad seat in a dry condition.
 17. The system ofclaim 14, the pad seat buffer material further comprising a lyophilizedbuffer material applied to the pad seat in a wet condition, wherein thepad seat including the wet buffer solution is lyophilized.